Depressive Disorder, MajorPhase 3RENEW-MDD-1NCT07412756
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
A Phase 3 study testing Brenipatide in people with Depressive Disorder, Major, run by Eli Lilly and Company at 181 sites in 15 countries.
Trial summary
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Brenipatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 181 sitesin 15 countries
- Study dates
- 9 Feb 2026to Feb 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for major depressive disorder
- Are on a stable standard of care medication for major depressive disorder
- Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
- self-inject study intervention
- store and use the provided blinded study intervention, as directed
- maintain electronic and paper study diaries, as applicable, and
- complete the required questionnaires
Who cannot join
- Have a lifetime history or current diagnosis of the following:
- schizophrenia or other psychotic disorder
- bipolar disorder
- borderline personality disorder, or
- any eating disorder.
- Have type 1 diabetes mellitus, or a history of
Show all 11Show fewer
- ketoacidosis, or
- hyperosmolar state or coma.
- Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
- Are actively suicidal or deemed a significant risk for suicide
- Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening
Trial locations and contacts
181 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
181 sites in 15 countries
United States32 sites, 32 recruiting
- Recruiting
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
410 602-1440
Sarah Herts
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
4254530404
Arun Arora
- Recruiting
Adams Clinical Boston
Boston, Massachusetts, 02116
(617) 744-8542
Dyanna Domilici
- Recruiting
Alpine Research Organization
Clinton, Utah, 84015
801-928-3292
Michael Roundy
- Recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
404-537-1281
Saundra Maass-Robinson
- Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Benji Kurian
- Recruiting
Re:Cognition Health
Fairfax, Virginia, 22031
Scott Williams
- Recruiting
Re:Cognition Health - Fort Worth
Fort Worth, Texas, 76104
Syed Quadri
- Recruiting
K2 Medical Research - Foxborough
Foxborough, Massachusetts, 02035
401-435-8950
john stoukides
- Recruiting
Encore Medical Research
Hollywood, Florida, 33024
954-400-1725
Juan Oms
- Recruiting
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202
3179637300
Stephen Strakowski
- Recruiting
Vector Clinical Trials
Las Vegas, Nevada, 89128
7027500000
Ann Childress
- Recruiting
K2 Medical Research - Maitland
Maitland, Florida, 32751
Sejal Patel
- Recruiting
Life Medical Research Group Corp
Miami Gardens, Florida, 33014
305-705-4111
Rafael Conte
- Recruiting
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016-1518
305-330-9977
Hortensia Valeron
- Recruiting
Accellacare - Moorpark
Moorpark, California, 93021
747-998-0394
Arjun Reyes
- Recruiting
CLA Research
Naples, Florida, 34116
2398378818
Evelia Iglesias
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06519
2039325711
Mohini Ranganathan
- Recruiting
Adams Clinical Harlem
New York, New York, 10029
917-423-67697
Rachel Noone
- Recruiting
ATP Clinical Research
Orange, California, 92866
9493545353
Gustavo Alva
- Recruiting
Optimal Research Sites
Orange City, Florida, 32763
3862185911
Antonio Cubano
- Recruiting
Charter Research - Orlando
Orlando, Florida, 32803
Jorel Martinez
- Recruiting
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
yvette sheline
- Recruiting
Summit Headlands
Portland, Oregon, 97210
5033143900
Beal Essink
- Recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
210-545-4900
Michelle Welch
- Recruiting
Circle Clinical Research
Sioux Falls, South Dakota, 57104
6052151159
Sophie Two Hawk
- Recruiting
Arch Clinical Trials
St Louis, Missouri, 63141
314-282-3521
Junaid Syed
- Recruiting
K2 Medical Research - Tampa
Tampa, Florida, 33634
813.800.5252
Kelley Wilson
- Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
248-312-0025
Neil Fraser
- Recruiting
Cedar Valley Medical Specialists
Waterloo, Iowa, 50701
319-888-8270
James Poock
- Recruiting
Adams Clinical Watertown
Watertown, Massachusetts, 02472
6177448542
Stephanie Ellickson
- Recruiting
Suburban Research Associates
West Chester, Pennsylvania, 19380
Omer Abdullah
Japan26 sites, 26 recruiting
- Recruiting
Abe Clinic - Arakawa
Arakawa City, 116-0014
81120023812
Tetsuo Abe
- Recruiting
Uematsu Mental Clinic
Chikugo, 833-0041
81120023812
Ken Uematsu
- Recruiting
Jimbocho Mental Clinic
Chiyoda City, 101-0051
81120023812
Koji Tada
- Recruiting
Fukuoka University Hospital
Fukuoka, 814-0180
81120023812
Hikaru Hori
- Recruiting
Kokorono Clinic Hirao
Fukuoka, 815-0071
81120023812
Naoko Kawano
- Recruiting
Horikoshi Mental Somatic Clinic
Fukushima, 960-8053
81120023812
Sho Horikoshi
- Recruiting
University of the Ryukyus Hospital
Ginowan, 901-2725
81120023812
Yoshikazu Takaesu
- Recruiting
Fujimidai Hospital
Hiratsuka, 259-1205
81120023812
Takafumi Yahoko
- Recruiting
Rainbow and Sea Hospital
Karatsu, 847-0031
81120023812
Taro Shindo
- Recruiting
Kishiro Mental Clinic
Kawasaki, 214-0014
81120023812
Masaki Kishiro
- Recruiting
Monzen-nakacho Mental Clinic
Kōtō City, 135-0047
81120023812
Junpei Sekiya
- Recruiting
Yuge Hospital
Kumamoto, 861-8002
81120023812
Masahiro Shono
- Recruiting
Suizenji Life Clinic
Kumamoto, 862-0956
81120023812
Tomohiko Matsuo
- Recruiting
Kure Medical Center
Kure, 737-0023
81120023812
Wataru Omori
- Recruiting
Hirota Clinic
Kurume, 830-0033
81120023812
Susumu Hirota
- Recruiting
Senzoku Psychosomatic Medicine Clinic
Meguro-ku, 152-0012
81120023812
Jun Matsushima
- Recruiting
Arata Clinic
Nagasaki, 852-8137
81120023812
Takatoshi Mori
- Recruiting
Yutaka Clinic
Sagamihara, 252-0303
81120023812
Hideo Muraoka
- Recruiting
Sangenjaya Shinkeika Shinryonaika Clinic
Setagaya City, 154-0004
81120023812
Jun Matsushima
- Recruiting
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
81120023812
Nobutoshi Kariya
- Recruiting
Nanko Kokorono Clinic
Shirakawa, 961-0021
81120023812
Seiji Hongo
- Recruiting
Sakurazaka Clinic SophyAnce
Tokyo, 106-0032
81120023812
Haruhito Muto
- Recruiting
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo, 162-0843
81120023812
Seiji Hongo
- Recruiting
Yamagata Sakuracho Hospital
Yamagata, 990-0045
81120023812
Nobuhiro Yokokawa
- Recruiting
Miki Mental Clinic
Yokohama, 220-0023
81120023812
Kazuhira Miki
- Recruiting
Shioiri Mental Clinic
Yokosuka, 238-0042
81120023812
Kenichi Goto
China22 sites, 22 recruiting
- Recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088
Gang Wang
- Recruiting
Beijing HuiLongGuan Hospital
Beijing, 100096
Yunlong Tan
- Recruiting
The Second People's Hospital of Hunan Province
Changsha, 410007
Xuhui Zhou
- Not yet recruiting
Chaohu Hospital of Anhui Medical University
Chaohu, 238001
Kai Zhang
- Recruiting
The Fourth People's Hospital of Chengdu
Chengdu, 610036
Feiyan Wang
- Recruiting
Guangzhou Brain Hospital
Guangzhou, 510370
Yuping Ning
- Recruiting
Peking University Sixth Hospital
Haidian District, 100191
Hongyan Zhang
- Recruiting
Hefei No.4 People's Hospital
Hefei, 230061
Jianliang Gao
- Recruiting
3rd People's Hospital of Huzhou
Huzhou, 313000
Jianjun Liu
- Recruiting
Shandong Daizhuang Hospital
Jining, 272051
Xia Liu
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330000
Tao Luo
- Recruiting
The Affilicated Kangning Hospital of Ningbo University
Ningbo, 315201
Yongming Xu
- Recruiting
Shanghai Mental Health Center
Shanghai, 200030
Wu Hong
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
Cuixia An
- Recruiting
Suzhou Guangji Hospital
Suzhou, 215003
Yansong Liu
- Recruiting
Tianjin Anding Hospital
Tianjin, 300022
Lina Wang
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, 430060
Huiling Wang
- Recruiting
Wuxi Mental Health Center
Wuxi, 214151
13358119629
Zhiqiang Wang
- Recruiting
Xi An Mental Health Center
Xi'an, 710061
Huali Lin
- Recruiting
Xianyang Hospital of Yan'an University
Xianyang, 712000
Xiaoke Hu
- Not yet recruiting
Zhenjiang Mental Health Center
Zhenjiang, 212000
Bei Zhao
- Recruiting
Zhumadian Psychiatric Hospital
Zhumadian, 463000
Hua Guo
Canada14 sites, 12 recruiting
- Not yet recruiting
Heritage Medical Research Clinic
Calgary, T2N 4Z6
+14032202130
Thomas Raedler
- Recruiting
Hamilton Medical Research Group
Hamilton, L8L 5G4
905 407 8945
Richard Tytus
- Not yet recruiting
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Eugene Okorie
- Recruiting
Alpha Recherche Clinique - Lévis
Lévis, G6V 0C9
Julie Beaudoin
- Recruiting
Genge Partners
Montreal, H4A 3T2
Simon Ducharme
- Recruiting
Dar Clinical Research - Ottawa
Ottawa, K2J 3Z6
Jabir Jassam
- Not yet recruiting
Centre de Recherche Saint-Louis inc.
Québec, G1W 4R4
418-780-3501
Catherine Vaillancourt
- Recruiting
Alpha Recherche Clinique
Québec, G2J 0C4
418-704-1112
Raphael Poulin-Robitaille
- Recruiting
ALPHA Recherche Clinique
Québec, G3K 2P8
418-847-1112
Jérôme Nadeau
- Recruiting
Richmond Clinical Trials
Richmond, V6V 2L1
604-373-4954
Harris Lari
- Recruiting
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3
1 (519) 344-6612
John O'Mahony
- Suspended
Diex Recherche Sherbrooke
Sherbrooke, J1L 0H8
- Not yet recruiting
Centre for Neurology Studies
Surrey, V3V 0E8
Shimi Kang
- Suspended
Maple Leaf Research
Toronto, M5G 1K2
Brazil11 sites, 11 recruiting
- Not yet recruiting
Hospital das Clínicas da UFMG
Belo Horizonte, 30130-100
31991990093
Frederico Garcia
- Recruiting
Trial Tech
Curitiba, 80240-280
41992061583
Hamilton Grabowski
- Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
5511944404464
Fernanda Guimarães
- Recruiting
Clinilive
Maringá, 87013-250
Antonio da Silva
- Recruiting
Hospital Universitário Onofre Lopes
Natal, 59012-300
Walter Soares
- Recruiting
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
55 21 35979708
Sandra Ruschel
- Recruiting
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, 09726-150
+55 11 99399-0508
Cintia de Azevedo Marques Périco
- Recruiting
CPQuali Pesquisa Clínica
São Paulo, 01228-000
+55 (11) 2776-6801
Moacyr Rosa
- Recruiting
CPCLIN
São Paulo, 01228-200
551126303777
Denise Franco
- Recruiting
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030
1126722734
Acioly Lacerda
- Recruiting
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, 13271-130
Caroline da Silva
United Kingdom10 sites, 10 recruiting
- Recruiting
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA
07958777103
Donald MacIntyre
- Recruiting
Devon Partnership Trust
Exeter, EX2 5AF
07973 831470
Merryn Anderson
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
(+44) 0141 232 7600
Nagore Penades
- Recruiting
The Maudsley Hospital
London, SE5 8AZ
Allan Young
- Recruiting
Clerkenwell Health - London - Welbeck Street
London, W1G 8DR
Alishah Suleman
- Recruiting
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, NG7 2UH
Neil Nixon
- Recruiting
Warneford Hospital
Oxford, OX3 7JX
Riccardo De Giorgi
- Recruiting
St Bartholomew's Medical Centre
Oxford, OX4 1XB
01865242 334
Carol Doan
- Recruiting
Atlantic Medical
Penzance, TR18 3DX
01736363741
John Ryan
- Recruiting
Woodstock Bower Surgery
Rotherham, S61 1AH
07551985998
Shahbaz Ali
Poland9 sites, 9 recruiting
- Recruiting
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756
48667980448
Jacek Dobryniewski
- Not yet recruiting
MentalMEDIC
Bielsko-Biala, 43-300
+48 662 234 338
Grzegorz Giemza
- Not yet recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
Grzegorz Kuczynski
- Recruiting
Diamond Clinic
Krakow, 31-559
+ 48 696 049 029
Barbara Rewerska
- Not yet recruiting
NZOZ Psychiatrycznej Mentis
Leszno, 64-100
Bartlomiej Krzewinski
- Recruiting
Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
Poznan, 60-192
Malgorzata Wojtanowska-Bogacka
- Not yet recruiting
Centrum Medyczne Euromedis
Szczecin, 70-111
Adam Lopuszko
- Recruiting
Centrum Medyczne Ginemedica
Wroclaw, 50-414
+48697555434
Katarzyna Okopien
- Not yet recruiting
Clinhouse Centrum Medyczne
Zabrze, 41-807
Joanna Moszant
South Korea9 sites, 9 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan-si, 15355
Saim Jung
- Recruiting
Chonnam National University Hospital
Gwangju, 61469
JAE-MIN KIM
- Recruiting
Jeju National University Hospital
Jeju City, 63241
JOON HYUK PARK
- Recruiting
Seoul National University Hospital
Seoul, 03080
YONGMIN AHN
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Chun Il Park
- Recruiting
Konkuk University Medical Center
Seoul, 05030
82-2-2030-7699
Hongjun Jeon
- Recruiting
Asan Medical Center
Seoul, 05505
Christopher Park
- Recruiting
Samsung Medical Center
Seoul, 06351
Hong Jin Jeon
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
Junhee Lee
Spain9 sites, 9 recruiting
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
+34932483175
Victor Pérez-sola
- Not yet recruiting
Institucion Hosp Hestia Palau
Barcelona, 08025
0034 635586700
Elena Ros Cucurull
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Josep-Antoni Ramos-Quiroga
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
93.2275400
Eduard Vieta
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Narcis Cardoner
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
+34619231150
Javier Quintero
- Not yet recruiting
Centro de Atención Integral La Corredoria
Oviedo, 33011
Pilar Sáiz
- Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37005
34639754620
ANGEL MONTEJO
- Recruiting
Complejo Asistencial de Zamora
Zamora, 49021
669462622
Manuel Franco-Martin
Germany8 sites, 8 recruiting
- Recruiting
Universitätsklinikum Aachen
Aachen, 52074
Thomas Frodl
- Recruiting
FutureMeds Berlin
Berlin, 10629
0049 30 4397410
Erik Lauterbach
- Recruiting
Neurozentrum Bielefeld
Bielefeld, 33647
49521443060
Judith Katzmann
- Recruiting
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, 09111
0800 - 1600
Ralf Bodenschatz
- Not yet recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131
+49 6131 17-2920
Susanne Englisch
- Recruiting
ISPG - Institut für Studien zur Psychischen Gesundheit
Mannheim, 68165
4962140046190
Georg Adler
- Recruiting
Somni bene
Schwerin, 19053
0049 385207980
Heike Benes
- Recruiting
ZNS Siegen
Siegen, 57076
4927131393710
Eugen Schlegel
Mexico8 sites, 8 recruiting
- Not yet recruiting
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Rafael Fernández
- Not yet recruiting
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650
Aura Garcia Aguilar
- Not yet recruiting
B&B Investigaciones Medicas S.C.
Mazatlán, 82103
52 669 146 3603
GABRIEL BERNAL
- Not yet recruiting
Medical Care and Research SA de CV
Mérida, 97070
Enrique Lara González
- Not yet recruiting
Ketamine Clinic México
Mexico City, 04100
55 15454240
MANUEL RUIZ FLORES
- Not yet recruiting
GabiPros
Mexico City, 07000
Miguel Herrera
- Not yet recruiting
Centro de Investigacion Clinica Chapultepec
Morelia, 58260
Misael Tapia Orozco
- Not yet recruiting
Arké SMO S.A de C.V
Veracruz, 91900
Samantha Aranda Pegueros
Taiwan8 sites, 8 recruiting
- Recruiting
Keelung Chang Gung Memorial Hospital
Keelung, 204
Chih-Ken Chen
- Recruiting
Chung Shan Medical University Hospital
Taichung, 402
Po-Chung Ju
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
+886-6-2353535ext.5213
Yen Kuang Yang
- Recruiting
National Taiwan University Hospital
Taipei, 10002
+886-23123456 ext 267991
I-Ming Chen
- Recruiting
Taipei Medical University Hospital
Taipei, 110
0970405254
Kuo-Hsuan Chung
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Ya-Mei Bai
- Recruiting
Cheng Hsin General Hospital
Taipei, 112
0228264400 ext3502
Tung Ping Su
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Huang-Li Lin
Australia7 sites, 7 recruiting
- Recruiting
NeuroCentrix
Carlton, 3053
61395460009
David Barton
- Not yet recruiting
Lyell McEwin Hospital
Elizabeth Vale, 5112
0881829554
Dennis Liu
- Recruiting
Barwon Health
Geelong, 3220
Roth Trisno
- Recruiting
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, 3004
Rebecca Ho
- Recruiting
Paratus Clinical Research - Melbourne
Melbourne, 3070
Paul Fitzgerald
- Recruiting
Toowoomba Hospital
Toowoomba, 4350
Vikas Garg
- Recruiting
Westmead Hospital
Westmead, 2145
Vlasios Brakoulias
Greece7 sites, 7 recruiting
- Recruiting
Argolida General Hospital
Argos, 212 00
Aikaterini Gamvroula
- Recruiting
Aiginiteio University Hospital
Athens, 115 28
NIKOS STEFANIS
- Recruiting
Multidisciplinary Mental Health Hospital of Attiki
Athens, 124 62
+302112054278
Christos Tsopelas
- Recruiting
Attikon General University Hospital
Chaïdári, 124 62
Nikolaos Smyrnis
- Recruiting
Multidisciplinary Mental Health Hospital of Thessaloniki
Stavroupoli, 564 29
Vasilios Bozikas
- Recruiting
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 564 29
LOUKAS ATHANASIADIS
- Recruiting
General Hospital of Tripoli Panarkadiko Evangelistria
Tripoli, 221 00
AIKATERINI GEORGOPOULOU
Puerto Rico1 site, 1 recruiting
- Recruiting
SCB Research Center
Bayamón, 00961
(787) 798-4592
William Julio
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms.
The trial is divided into four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.
- Conditions
- Depressive Disorder, Major
- Being tested
- Brenipatide, Placebo
- Keywords
- Major Depressive Episode, Mood Disorders, Depression, Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Mood Disorders, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrenipatideDrug
Also called LY3537031
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Brenipatide Dose 1 | Experimental | Brenipatide administered subcutaneously (SC) + standard of care (SoC). Receives: Drug: Brenipatide |
| Brenipatide Dose 2 | Experimental | Brenipatide administered SC + SoC Receives: Drug: Brenipatide |
| Brenipatide Dose 3 | Experimental | Brenipatide administered SC + SoC Receives: Drug: Brenipatide |
| Placebo | Placebo comparator | Placebo administered SC + SoC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)
Measured: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months
Secondary outcomes (11)
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2
Measured: Baseline, Up to at Least 6 Months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Measured: Baseline, Up to at Least 6 Months
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Measured: Baseline, Up to at Least 6 Months
Change from Baseline in Patient Global Impression of Severity (PGI-S)
Measured: Baseline, Up to at Least 6 Months
Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score
Measured: Baseline, Up to at Least 6 Months
Change from Baseline in Patient Rated Symptom and Disease Severity
Measured: Baseline, Up to at least 6 months
Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score
Measured: Baseline, Up to at Least 6 Months
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic
Measured: Baseline, Up to at Least 6 Months
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Measured: Predose Up to at Least 6 Months
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)
Measured: Baseline Up to at Least 6 Months
Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form
Measured: Baseline, Up to at Least 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start9 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412756
- Sponsor's protocol ID
- 27363
- Other IDs
- 2025-522308-25-00, J2S-MC-GZMH, 2025
- Acronym
- RENEW-MDD-1
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.